Harmonic HAR1136Recalls & reported problems
Ethicon Endo-Surgery, LLC · HARMONIC 1100 Shears, 36cm Shaft Length · Class U
Quick summary
This Ethicon Harmonic shears is an ultrasonic surgical instrument. Its 1,578 reports mostly describe the instrument failing to read its input signal and parts separating, and some describe delayed activation or the device stopping during surgery. The reports mention 2 deaths and 36 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,538
- Deaths reported
- 2
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,538 adverse event reports that list this exact device (DI 10705036026167), received between Apr 12, 2021 and Sep 29, 2026 — classified as 2 deaths, 36 injuries, 1,500 malfunctions.
The most frequently reported specific device problem is “Failure to Read Input Signal” (876 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Read Input Signal876
- Material Separation553
- Difficult or Delayed Activation119
- Insufficient Device Problem Information70
- Detachment of Device or Device Component61
- Material Integrity Problem48
- Activation, Positioning or Separation Problem32
- Noise, Audible23
Patient problems
- No Clinical Signs, Symptoms or Conditions1,501
- Hemorrhage/Blood Loss/Bleeding17
- Insufficient Information7
- Burn(s)4
- Failure to Anastomose4
- Abdominal Pain3
- Foreign Body In Patient3
- Perforation3
Recent adverse event reports
The 25 most recent of 1,538 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935730 ↗MalfunctionSep 28, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917414 ↗MalfunctionSep 28, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916899 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915938 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during an unknown procedure the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913733 ↗MalfunctionSep 28, 2026Failure to Read Input Signal
It was reported that during an unknown procedure there was an issue with the device. It could not be registered by the generator. They tried a different device and there was no issue. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913230 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890042 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889526 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889205 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885314 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the ¿Replace Instrument¿ alert screen was displayed. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885213 ↗MalfunctionSep 23, 2026Material Integrity Problem
It was reported that during an unknown procedure the device blade fractured. The device could not be used further and was replaced with a new device. No patient consequences reported when this complaint event occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869591 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the ¿Replace Instrument¿ alert screen was displayed. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869458 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the screen displayed the message "Replace instrument". A new device was installed; however, the same message alarm recurred shortly after use. A second replacement with another new device was performed, but the issue persisted. The procedure was ultimately completed successfully using an alternative manufacturer's product. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869404 ↗MalfunctionSep 22, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860066 ↗MalfunctionSep 22, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859720 ↗MalfunctionSep 22, 2026Material Separation; Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858961 ↗MalfunctionSep 22, 2026Material Separation
It was reported that during a Pancreas Procedure the titanium tip broke off. Changed to another device to complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858812 ↗MalfunctionSep 22, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857545 ↗MalfunctionSep 22, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856781 ↗MalfunctionSep 22, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the generator displayed the message ¿Clean the blade.¿ The blade was cleaned according to the on-screen instructions, and the device was activated for approximately 2 seconds with the jaws open. The generator then displayed a second message indicating ¿Damaged blade ¿ replace Harmonic instrument.¿The device was disconnected and reconnected; however, the same error message reappeared. The device had been used correctly throughout the procedure, and cleaned regularly with a moist gauze pad in accordance with recommended practice. There was no impact on the patient. The procedure was only slightly prolonged due to troubleshooting and replacement of with a new device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856414 ↗MalfunctionSep 22, 2026Activation, Positioning or Separation Problem
It was reported that during a Lobectomy procedure the scalpel was hard to cut. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854513 ↗MalfunctionSep 22, 2026Difficult or Delayed Activation
It was reported that during an unknown procedure the device did not work in the middle of use. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854120 ↗MalfunctionSep 22, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the ¿Replace Instrument¿ alert screen was displayed. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853745 ↗MalfunctionSep 22, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the ¿Relax Pressure on Blade¿ alert screen displayed by the generator. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853367 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic ACE HARH36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical4 deaths7,609 reports
- Harmonic HARHD36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- Harmonic ACE HAR36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2,726 reports
- THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls1,373 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls2 deaths1,128 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical2 recalls1 death970 reports
- Harmonic ACE HARH23Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical935 reports
- Harmonic Ace ACE36EEthicon Endo-Surgery, LLC · Instrument, ultrasonic surgical860 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.